An Open-label, Multicenter Phase II Study to Compare the Efficacy and Safety of RAD001 as First-line Followed by Second-line Sunitinib Versus Sunitinib as First-line Followed by Second-line RAD001 in the Treatment of Patients With Metastatic Renal Cell Carcinoma.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess if Progression Free Survival (PFS) after first-line of treatment in patients who receive RAD001 will be non-inferior to the PFS of patients who receive sunitinib after first-line treatment.
6 - 12 months
No
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CRAD001L2202
NCT00903175
October 2009
June 2014
Name | Location |
---|---|
Cooper Cancer Center | Voorhees, New Jersey 08043 |
East Texas Medical Center Cancer Institute | Tyler, Texas 75701 |
Summit Cancer Care | Savannah, Georgia 31405 |
Arena Oncology Associates, PC | Great Neck, New York 11021 |
Lynn Cancer Institute | Boca Raton, Florida 33428 |
Georgia Health Sciences University Dept. of MCG | Augusta, Georgia 30912 |
Levine Cancer Institute Oncology | Charlotte, North Carolina 28203 |
University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst. | Mobile, Alabama 36688 |
Weinberg Cancer Institute at Franklin Square Hospital | Baltimore, Maryland 21237-3998 |
Northeast Georgia Cancer Care Dept of NE Georgia Cancer (2) | Athens, Georgia 30607 |
The West Clinic Dept. of the West Clinic | Memphis, Tennessee 38120 |
Highlands Oncology Group HighlandsOncGrp-Bentonville(2) | Fayetteville, Arkansas 72703 |
University of California San Diego Dept of Moores Cancer Ctr (5) | La Jolla, California 92093-0658 |
University of Colorado Dept. of Anschutz Cancer (2) | Aurora, Colorado 80045 |
Memorial Sloan Kettering Cancer Center Dept. of MSKCC | New York, New York 10021 |
SUNY - Upstate Medical University Div. of Hematology-Oncology | Syracuse, New York 13210 |
Utah Cancer Specialists Dept.of Utah Cancer Spec. (3) | Salt Lake City, Utah 84103 |
Hematology and Oncology Specialists SC | Metairie, Louisiana 70006 |
The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2) | Fort Worth, Texas 76104 |
University of Alabama at Birmingham/ Kirklin Clinic Comprehensive CancerCenter (1) | Birmingham, Alabama 35294-0006 |
University of California at Los Angeles Dept. of UCLA (3) | Los Angeles, California 90095 |
Norwalk Hospital Norwlak SC | Norwalk, Connecticut 06856 |
Georgetown University/Lombardi Cancer Center Dept.of Lombardi Cancer Ctr (2 | Washington, District of Columbia 20007-2197 |
University of Miami SC | Miami, Florida 33136 |
MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando | Orlando, Florida 32806 |
NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Dept.ofNorthwesternMemHospital | Chicago, Illinois 60611 |
Loyola University Medical Center /Cardinal Bernardin Cancer Cardinal Bernardin Cancer (3) | Maywood, Illinois 60153 |
VA Maryland Health Care Dept.of GreenbaumCancerCent(7) | Baltimore, Maryland 21201 |
Billings Clinic Dept of Billings Clinic(2) | Billings, Montana 59107 |
Hackensack University Medical Center DeptofHackensackUniv.MedCtr. | Hackensack, New Jersey 07601 |
UNC/ Lineberger Comprehensive Cancer Center Dept. of LinbergerCancerCtr(3) | Chapel Hill, North Carolina 27599-7295 |
Duke University Medical Center Duke | Durham, North Carolina 27710 |
University of Oklahoma Health Sciences Center Dept of OHSC | Oklahoma City, Oklahoma 73104 |
St. Luke's Hospital and Health Network St Luke's Hospital (2) | Bethlehem, Pennsylvania |
Aurora Advanced Healthcare SC | Milwaukee, Wisconsin 53215 |